Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)

Completed

• Conditions: Coronary Artery Disease; Aortic Stenosis

• Registration Number: NCT04026204
• Lead Sponsor: University of Catania

Brief Summary

With the upcoming expansion of transcatheter aortic valve replacement (TAVR) indications to younger patients, the feasibility of coronary ostia cannulation beyond different bioprosthesis stent is currently a matter of debate. Purpose of this study is: 1) to assess the feasibility to re-engage coronary ostia after TAVR; 2) to discover potential native anatomical or prosthesis-related features that may preclude proper coronary cannulation after TAVR.

Detailed Description

Single-center, prospective, pilot study. Aim of this study is to assess the feasibility of coronary ostia re-engagement beyond transcatheter aortic valve (TAV) stent through a transfemoral access in 300 consecutive patients undergoing transfemoral TAVR with pre-procedural computed tomography assessment available.

The possibility to selectively cannulate each coronary, the amount of time and contrast will be evaluated in each patient before and after implantation of either balloon-(SAPIEN 3) or self-expanding (Evolut R/PRO, Acurate Neo or Portico) TAVs, thus generating an internal comparator.

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-06-12
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-19
• Primary Completion: 2020-01-31
• Study Completion: 2020-02-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-04
• Last Update Posted: 2020-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Consecutive patients with severe aortic stenosis undergoing TAVR with all commercially available devices
• Availability of preprocedural aortic root evaluation by computed tomography angiography scans

Exclusion Criteria

• TAVR in degenerated bioprostheses
• Known ostial chronic total occlusion
• Transcatheter valve not deployed in its anatomical position
• Patients with hemodynamic instability during the procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients in whom it was possible to selectively cannulate coronary ostia after TAVR	5 minutes	Angiographic assessment of coronary ostia selective cannulation after TAVR

Secondary Outcome Measures

Name	Time	Method
Hazard ratios of factors associated with the inability to selectively cannulate coronary ostia after TAVR	5 minutes	Aortic root CTA measurements and prosthesis implantation-related factors associated with inability to selectively cannulate coronary ostia after TAVR at multivariate regression analysis

Trial Locations

Locations (1)

Department of Cardiology, CAST, AU Policlinico-Vittorio Emanuele; 🇮🇹 Catania, Italy